Implantable system for Remodulin receives FDA approval
Medtronic has received FDA approval for the Implantable System for Remodulin (ISR) to treat patients with pulmonary arterial hypertension (PAH). Through a first-of-its-kind collaboration, the Medtronic SynchroMed II drug delivery system and cardiac catheter technologies were leveraged to deliver the PAH medication Remodulin (treprostinil) Injection developed by United Therapeutics. United Therapeutics will lead the commercial promotion ...
MiniMed 670G hybrid closed loop system receives CE Mark
Medtronic has announced it has received CE (Conformité Européenne) Mark for the MiniMed 670G hybrid closed loop system - the first and only system to automate and personalise the delivery of basal insulin 24 hours a day. The system is CE Mark approved for the treatment of people with type 1 diabetes 7 years of age and older with ongoing studies to expand the indication to additional patient populations.
DBS Clinician Programmer addresses day-to-day management challenges
Medtronic has announced that the FDA recently approved its Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application, which followed closely on the recent achievement of CE Mark this past March. The ActivaProgramming Application has been designed with the input of over a hundred clinicians from around the world and is managed on the Samsung Galaxy Tab S2 tablet interface.
Continuous glucose monitoring system receives FDA approval
Medtronic has announced it received FDA approval for its Guardian Connect continuous glucose monitoring (CGM) system, for people with diabetes ages 14 to 75 years. The Guardian Connect system is the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose events. The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.
Advance Infusion Set: a simple change for the better
Medtronic has announced the Minimed Mio Advance Infusion Set, designed with a pre-loaded inserter for quicker and easier set changes that require fewer steps. It works with major pump brands with luer-lock or Minimed connectors including Medtronic, Roche and Animas.
Intravenous delivery system for treprostinil
Current guidelines in the United States and Europe recommend treatment with parenteral prostanoids for severe or rapidly progressing pulmonary arterial hypertension (PAH).2-4 However, risks and complexities associated with the current intravenous (IV) and subcutaneous (SC) delivery systems limit the acceptance of parenteral therapy. IV delivery via an indwelling central venous catheter is associated with the risk of serious bloodstream infections...
World's smallest fully implantable SCS receives CE Mark
Medtronic has announced that it received CE Mark for the Intellis platform for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) as an aid in the management of certain types of chronic pain. Intellis, the world's smallest fully implantable SCS neurostimulator, simplifies and improves the patient experience with improved battery performance that can power the EvolveSM workflow, which standardises guidance and balances high-...
HeartWare approved for destination therapy
Medtronic plc has received FDA approval for its HeartWare HVAD System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body.
Detachable coil system aids peripheral vasculature
At the ongoing Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in Copenhagen, Denmark, Medtronic has unveiled its new Concerto 3D Detachable Coil System. The device, which is now available to physicians in the U.S. and Europe, is intended to be used for embolisations in the peripheral arteries and veins. The device folds into a dense and knotty shape which helps to fill in an aneurysm, for example, similar to...
Next-gen spinal cord stimulator receives FDA Approval
Medtronic has announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSM workflow*, which standardises guidance and balances high-dose (HD) and low-dose (LD) therapy settings.
Attain Stability Quad MRI SureScan receives CE Mark
Medtronic has announced it has received CE Mark for the Attain Stability Quad MRI SureScan left heart lead. Paired with Medtronic quadripolar cardiac resynchronisation therapy-defibrillators (CRT-D) and -pacemakers (CRT-P), the Attain Stability Quad lead features novel, active-fixation technology that is designed for precise lead placement and stability. In the United States, the Attain Stability Quad lead is under evaluation in a clinical trial ...
Pericardial aortic surgical valve approved in U.S. and Europe
Medtronic plc has announced CE mark and U.S. FDA approval of its new Avalus pericardial aortic surgical valve for the treatment of aortic valve disease. The Avalus valve leverages proven surgical bioprosthetic valve concepts with added features designed to enhance clinical performance, helping to address the contemporary needs of cardiac surgeons, as well as patients who are candidates for aortic valve replacement.
CoreValve Evolut PRO receives CE Mark and European launch
Medtronic plc has announced CE mark and European launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at intermediate, high or extreme risk for open heart surgery. Clinical data for the Evolut PRO valve was recently unveiled at the American College of Cardiology (ACC) 66th Annual Scientific Session, and showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and e...
Micra pacemaker survives flight to space
The Medtronic Micra is the smallest pacemaker currently available. It’s so small that it’s delivered via a catheter and attached to the endocardium of the heart, where its internal battery paces the heart for years. It’s certainly an incredible piece of technology, but a high school student had a wild idea of testing whether such a fine piece of electronics can withstand a flight into space.
Micra pacemaker goes on a space flight
These days astronauts are some of the healthiest and physically robust individuals that NASA can get a hold of. But one day we may see all kinds of people going to space, even those with heart conditions. Shelbi Klingsporn, a Nebraska high school student had the idea to test whether an existing pacemaker is able to handle the vibrations, radiation, and weightlessness of space to get a sense of whether pacemakers have a future in the final frontie...
World's first hybrid closed loop system treats Type 1 diabetes
Medtronic has announced the U.S. launch of the MiniMed 670G system - the world's first Hybrid Closed Loop system for people with type 1 diabetes. Featuring the company's most advanced SmartGuard HCL technology and Guardian Sensor 3, it is the only insulin pump approved by the FDA that enables personalised and automated delivery of basal insulin, the background insulin needed to maintain stable blood sugar levels throughout the day and night.
Platform offers advanced visualisation for procedural workflows
Medtronic has launched its new StealthStation technology at the AANS annual conference in Los Angeles. StealthStation technology has been a mainstay in neurosurgery suites for the past 25 years, being used in more than 2.25 million procedures. With the new StealthStation S8 model, Medtronic brings an advanced solution to neurosurgeons with enhanced workflows, efficiencies, and more comprehensive data integration, providing useful surgical na...
CoreValve Evolut Pro valve receives FDA approval
Medtronic has announced FDA approval and U.S. launch of the CoreValve Evolut PRO valve for the treatment of severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval comes on the heels of new 30-day clinical data that was unveiled at the ACC 66th Annual Scientific Session, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and hemodynamics for the self-expand...
Surgical stapler measures tissue strength
Medtronic has released an advanced surgical stapler, the Signia Stapling System, which sports sensors that detect the tissue being worked and adjust its speed to produce optimal staple lines. The company’s Adaptive Firing technology measures how much force it takes a staple to penetrate through tissue, controlling in real-time the speed of the stapler. The tissue sensing data and status of the stapler, including the battery charge, is ...
Products aid diagnostic cath procedures
Medtronic is releasing a few coronary devices, including the DxTerity diagnostic angiography catheters, DxTerity TRA diagnostic catheters, InTRAkit access kit, and the TRAcelet compression device. All the products already have received U.S. and European regulatory approvals.